- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
In pediatric patients (6-17 years):
Tmax: 5 h
T½: 18 h
The pharmacokinetics of guanfacine in children (6 to 12 years) and adolescents (13 to 17 years) with ADHD and adults are comparable.
[SmPC Intuniv]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| ADHD |
|---|
|
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Renal impaiment in children > 3 months
In cases of severely reduced renal function (creatinine clearance less than 30 ml/min), dose reduction may be needed.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Very common (> 10%): drowsiness (in 41%), headache (in 27%). Abdominal pain. Fatigue.
Common (1-10%): decreased appetite, weight gain. Depression, anxiety, affectlability, insomnia, sleep disturbance, nightmare, irritability, sedation. Dizziness, lethargy. Bradycardia, (orthostatic) hypotension. Vomiting, diarrhea, nausea, constipation, dry mouth. Skin rash. Bedwetting.
Uncommon (0.1-1%): hypersensitivity. Agitation, aggression, hallucination. Convulsion, syncope. First-degree AV block, tachycardia, sinus arrhythmia. Paleness. Asthma. Dyspepsia. Itching. Pollakisuria. Asthenia, chest pain, decreased heart rate. Increased ALAT.
Rare (0.01-0.1%: hypersomnia. Hypertension. Malaise.
Very rarely (< 0.01%): hypertensive encephalopathy (due to rise in blood pressure after sudden discontinuation of treatment).
Also reported: suicidal thoughts and suicidal behavior (especially with underlying mental illness). Erectile dysfunction.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Prior to treatment, assess the patient's increased risk of hypotension, bradycardia, arrhythmia with QT prolongation; To do this, make an inventory of the cardiovascular status, including heart rate, blood pressure and whether there is a family history of sudden death (due to the heart or unexplained). Use caution if you have a history of hypotension, heart block, bradycardia, history of QT prolongation, risk factors for torsade de pointes (such as hypokalaemia) or cardiovascular disease, or if you have a history of syncope or any condition that makes the patient more prone to syncope, such as (orthostatic) hypotension, bradycardia or dehydration. Advise patients to drink a lot. During dose titration, monitor heart rate and blood pressure weekly, at least every 3 months for the first year and then every 6 months (more frequently after dose adjustment). Continue to monitor blood pressure during tapering and after stopping treatment, as an increase in blood pressure may occur.
Check height, weight and BMI before treatment, every 3 months for the first year and every 6 months thereafter.
During dose titration, monitor weekly for symptoms of somnolence, sedation, hypotension and bradycardia. Evaluate at least every 3 months during the first year of treatment and then every 6 months for symptoms of somnolence, sedation, hypotension, bradycardia and weight gain / risk of obesity; monitor more frequently after each dose adjustment.
Monitor for signs of suicidal events, including at initiation or termination of treatment and at dose adjustment. This is because of reports of these during treatment with guanfacine. Usually these patients had underlying mental illness. Also monitor for signs of aggressive behavior or hostility during treatment.
Use of this drug has moderate to severe effects on driving ability. Avoid operating machinery, driving vehicles and riding a bicycle until the patient knows how he or she responds to treatment.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Imidazoline receptor agonists | ||
|---|---|---|
| C02AC01 | ||
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Reference
- Shire Pharmaceuticals Ireland Limited, SmPC Intuniv (EU/1/15/1040/001-009) 08-11-2016, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
